alecensa

Generic: alectinib hydrochloride

Labeler: genentech, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name alecensa
Generic Name alectinib hydrochloride
Labeler genentech, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

alectinib hydrochloride 150 mg/1

Manufacturer
Genentech, Inc.

Identifiers & Regulatory

Product NDC 50242-130
Product ID 50242-130_abdb3f90-4a44-4404-a49c-8d3bbc4dd13b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208434
Listing Expiration 2026-12-31
Marketing Start 2015-12-11

Pharmacologic Class

Classes
kinase inhibitor [epc] kinase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50242130
Hyphenated Format 50242-130

Supplemental Identifiers

RxCUI
1727479 1727485
UNII
P9YY73LO6J

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name alecensa (source: ndc)
Generic Name alectinib hydrochloride (source: ndc)
Application Number NDA208434 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (50242-130-01) / 240 CAPSULE in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (50242-130-86) / 240 CAPSULE in 1 BOTTLE, PLASTIC
source: ndc

Packages (2)

50242-130-01 1 BOTTLE, PLASTIC in 1 CARTON (50242-130-01) / 240 CAPSULE in 1 BOTTLE, PLASTIC 50242-130-86 1 BOTTLE, PLASTIC in 1 CARTON (50242-130-86) / 240 CAPSULE in 1 BOTTLE, PLASTIC

Ingredients (1)

alectinib hydrochloride (150 mg/1)

Linked Drug Pages (1)

ALECENSA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "abdb3f90-4a44-4404-a49c-8d3bbc4dd13b", "openfda": {"unii": ["P9YY73LO6J"], "rxcui": ["1727479", "1727485"], "spl_set_id": ["42c49deb-713b-427a-9670-08af08adcffb"], "manufacturer_name": ["Genentech, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (50242-130-01)  / 240 CAPSULE in 1 BOTTLE, PLASTIC", "package_ndc": "50242-130-01", "marketing_start_date": "20151211"}, {"sample": true, "description": "1 BOTTLE, PLASTIC in 1 CARTON (50242-130-86)  / 240 CAPSULE in 1 BOTTLE, PLASTIC", "package_ndc": "50242-130-86", "marketing_start_date": "20171010"}], "brand_name": "ALECENSA", "product_id": "50242-130_abdb3f90-4a44-4404-a49c-8d3bbc4dd13b", "dosage_form": "CAPSULE", "pharm_class": ["Kinase Inhibitor [EPC]", "Kinase Inhibitors [MoA]"], "product_ndc": "50242-130", "generic_name": "ALECTINIB HYDROCHLORIDE", "labeler_name": "Genentech, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ALECENSA", "active_ingredients": [{"name": "ALECTINIB HYDROCHLORIDE", "strength": "150 mg/1"}], "application_number": "NDA208434", "marketing_category": "NDA", "marketing_start_date": "20151211", "listing_expiration_date": "20261231"}